Keverprazan plus amoxicillin versus rabeprazole-based therapy for first-line H. pylori treatment

Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment

This test will see if Keverprazan plus amoxicillin for 10 or 14 days clears H. pylori in adults as well as or better than the standard rabeprazole quadruple therapy.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 414 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07122024 on ClinicalTrials.gov

What this trial studies

This open-label, randomized controlled Phase 4 study will enroll 414 adults with confirmed H. pylori infection and randomize them 1:1:1 to Keverprazan dual therapy for 10 days, Keverprazan dual therapy for 14 days, or rabeprazole quadruple therapy for 14 days. The protocol includes a screening visit and three on-treatment visits (one may be by phone) to record vitals, concomitant medications, adverse events, and adherence. The project duration is approximately one year from ethics approval and clinical registration, with eradication and safety compared across groups. Eligible participants are adults 18–65 who are treatment-naïve for H. pylori and meet the study’s washout and health criteria.

Who should consider this trial

Good fit: Adults aged 18–65 with confirmed H. pylori infection who have never received eradication therapy, can give informed consent, complete study procedures, and meet washout requirements for antibiotics and acid-suppressing drugs.

Not a fit: Patients with prior H. pylori eradication, recent antibiotic or acid-suppressant use, active complicated peptic ulcer disease, major organ failure, or inability to attend the Hangzhou site are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the Keverprazan dual regimen could offer a simpler or shorter first-line option with similar or better eradication rates and potentially fewer drugs.

How similar studies have performed: Other potassium-competitive acid blocker plus amoxicillin regimens (for example, vonoprazan–amoxicillin) have shown promising eradication rates in prior trials, though Keverprazan-specific evidence is more limited.

Eligibility criteria

Inclusion Criteria

1. Adult patients aged 18 to 65 years old, regardless of gender;
2. H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture;
3. No previous history of H. pylori eradication therapy;
4. Subjects able to independently complete the recording of the subject diary card;
5. Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.

Exclusion Criteria

1. Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment;
2. Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
3. Previous history of esophageal or gastric surgery;
4. Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
5. Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.);
6. Female participants who are pregnant, breastfeeding;
7. Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events;
8. Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators;
9. Deemed unsuitable for participation in the study by the investigator for any other reason.

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Qin Du — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Jun Ye

Conditions Helicobacter Pylori